Whitepapers

Drug products in development require compatible packaging to meet milestones and gain approval. West supports pharmaceutical partners with a data-driven process to give you confidence with closure containment that meets requirements in the modern regulatory landscape.

Small pharmaceutical companies are constantly seeking innovative solutions to streamline early clinical trials. Adaptive clinical trials offer important benefits to sponsors and patients, both from a commercial and ethical standpoint. These trials offer flexibility and efficiency, especially in the early stages, where trial protocols can be adjusted based on interim data, such as introducing new doses or modifying participant sample size. However, adjusting manufacturing demand during an adaptive trial can be complicated, and strict regulatory requirements present significant challenges. On-demand manufacturing provides a robust solution, allowing for real-time supply and demand adjustments and improved trial flexibility. This paper explores how on-demand manufacturing meets the operational needs of adaptive trials and aligns with regulatory expectations.

Glycosylation is a common and critical post-translational modification that affects protein function and therapeutic efficacy, making its monitoring and accurate quantification essential for drug development.

As described in the chapter subsection USP <1207.3> Package Seal Quality Test Methods, the measurement of residual seal force (RSF) indicates the quality of the vial package seal, giving insight into the quality of the sealing process. Correlating RSF to CCI data enables optimization and validation of the vial sealing process with parameters that give assurance of good CCI. This Case Study describes how science-based statistically valid RSF data was generated on the vial sealing process and combined with CCI data to ensure good CCI of sterile product needing deep cold storage

Download this Case Study to learn how a purging process qualification study was performed using rapid non-destructive headspace oxygen analysis in an at-line set-up with samples being measured immediately from the line.

This new case study demonstrates how a non-destructive container closure integrity test method can be developed for autoinjectors with an optically transparent window.

Created specifically for the pharma biotech industry by Veltek Associates, Core2Scan is the tracking, asset management, and process improvement solution that boosts bottom lines and so much more. Powered by RFID, Core2Scan keeps tabs on any onsite physical asset your organization wants to track. Better yet, its invaluable data can drive smarter processes and savings throughout your entire G-M-P facility.

This technical note explores the sources of error in gravimetric measurements used for aerosol photometer calibration, emphasizing the impact of discrepancies in aerosol properties, temporal instability, and flawed experimental procedures. It supports the two-point calibration practice to minimize errors, particularly at lower concentrations, and recommends measures such as improved aerosol systems and automation to enhance calibration accuracy. The findings aim to ensure reliable photometer performance for critical applications.

This technical note discusses the rationale for using two-point calibration and multi-point verification in the calibration of aerosol photometers. It explains the theoretical basis for the linear relationship between photometric response and aerosol mass concentration, highlights practical challenges with multi-point calibration, and advocates for two-point calibration to minimize errors. The combination of two-point calibration and multi-point verification ensures the accuracy and performance of the photometer in critical applications.

Example of how we offer creative and interesting solutions to our customers to improve efficiency in production.

We want to inform our customers that we have an excellent tech center available to assist them to develop together tailor-made solutions and personalized technologies, solve problems and complete hands-on training on our machines.

Highlighting the importance for our clients to prepurchase multi-year maintenance contracts, in order to avoid their machines breaking or stopping to work suddenly and unexpectedly, to minimize the risk of interrupted production and emergency maintenance costs.

Lipid nanoparticle (LNP) formulation development begins on a small scale, often with homemade or benchtop setups, using syringe pumps and easily accessible micro-mixing systems. Once a promising formulation has been identified, the next step is to transition to standardized large-scale impingement mixing systems, such as the high flow T-mixing pumps that were used to produce the COVID-19 vaccines (Sealy 2021). Formulators need to consider a number of factors when scaling up novel LNP systems. These include flow rates that affect LNP particles, solvent removal, risk factors when changing equipment, and the impact of tangential flow filtration sensitivity. In this technical note, we discuss these factors and what needs to be considered when developing a cost- and time efficient large-scale process.

A must-read for anyone in the industry looking to enhance their micronization processes. Discover how adding low percentages of SYLOID® mesoporous silica can significantly improve the run time and yield of jet milling processes for hard-to-process Active Pharmaceutical Ingredients (APIs). Imagine achieving a more consistent feed rate and a homogenous final product simply by pre-blending SYLOID® mesoporous silica with your APIs. Grace & Microsize conducted experiments that reveal substantial improvements in both run time and yield, making this paper an essential guide for professionals aiming to optimize their manufacturing processes and boost efficiency and feed rate consistency.

An article describing the technological advancement from one process controller to the new one.

Stevanato Group’s integrated offering addressing mAbs challenges includes Aidaptus®, a 2-step single-use auto-injector accommodating 1mL and 2.25mL PFSs in the same base device, supporting a range of drug viscosities for reliable delivery.

Don't miss this webinar delving into: - How to streamline the selection of the primary container and delivery device - How to overcome silicone challenges in PFSs - How to enhance the delivery of highly viscous drug formulation

The release of subvisible silicone particles and the risks associated with silicone oil droplets are major factors that can compromise the safety and efficacy of sensitive drugs. Download this white paper and discover how Stevanato Group's innovative syringe platform answers this challenge.

For new drug products, it is essential that pharmaceutical companies utilize the experience of container suppliers as early as possible. Read this white paper and discover how Stevanato Group can support you from start to finish.